Neuro Pace and guinea pig

[vtsammy]

I spoke w/ my neurosurgeon's coordinator for the neurologist Pace and I found out some disturbing information. First off, she told me that I was a good candidate to have the neurologist Pace surgery. I thought this was great until she told me that the neurologist Pace has a battery that needs to be replaced every 1 1/2-2 years. Which means every 2 years I have to have brain surgery again to replace the battery. And the most disturbing thing she told me is that 10% of the patients in their study became seizure free, 10% seizure activity got worst, and 80% of the patients nothing had changed. Especially since this is a still new (3 years), I don't think this is anything I want to get involved in. I feel like I'm just merely a guinea pig. Any thoughts guys and gals?

[POSITIVEPERSON]

I agree with you, I would wait and check out homeopathy or the gard diet instead. Or both!!!!!!!!! Wishing you a seizure free life!!!!!!!

Riva

[vtsammy]

Positiveperson,

How long have these different diets been out there for? And why haven't any of the many neurologists I've seen ever mentioned them to me? I would have loved to try one of these diets instead of being drugged with all sorts of different medications I've tried in the past?

[Bernard]

I haven't seen any results of the NeuroPace trials published anywhere. I don't think they will be publishing results until after the trials are finished.

Of course, by signing up for a clinical trial, you are assenting to be a guinea pig. That's the nature of clinical trials.

The Ketogenic diet has been around for at least a century. The Modified Atkins Diet and Low Glycemic Diet are both fairly new. The initial studies for them were published within the last few years.

The GARD diet is even newer and is just starting to get attention for a clinical trial.

It's possible your docs aren't up to date. Why not ask them about these possibilities? (Hint: print out the info I've published on the chart so when you go to ask, you can point them to the studies)

[Bernard]

... she told me that the Neuro Pace has a battery that needs to be replaced every 1 1/2-2 years. Which means every 2 years I have to have brain surgery again to replace the battery....

The generator is placed inside the brain? That seems odd. I never paid attention to that. I assumed it would be similar to the VNS where the generator is placed somewhere near the chest.

[vtsammy]

Thanks for the update Bernard. But to answer your question, yes the battery is placed inside the chip in the brain. That's why I'm not so enthusiastic about getting the neurologist Pace because they'll have to slice my head open every 2 years.

[Birdbomb]

Positiveperson,

How long have these different diets been out there for? And why haven't any of the many neurologists I've seen ever mentioned them to me? I would have loved to try one of these diets instead of being drugged with all sorts of different medications I've tried in the past?

Big Pharma make$ drug$, drug$ don't cure only treat the $ymotom$. Doctor$ make money by pre$cribing the drug$ big pharma make$. $o, diet$ don't make money for big pharma or Doctor$, $o they are more or le$$ overlooked or even $hunned by our beloved medical profe$$ional$.

[POSITIVEPERSON]

In Portland alternative medicine is accepted by the traditional Drs. But when I was in NYC and Mtl the traditional Drs were against me getting acupuncture for the side effects from the meds .

The drs and pharacuiticals are into power and money !!!!!

Me I am into feeling good and living my life to the fullest without problems.
Diet and homeopathy is what has given me that!!!!!

Riva

[brain]

The generator is placed inside the brain? That seems odd. I never paid attention to that. I assumed it would be similar to the VNS where the generator is placed somewhere near the chest.

Bernard - that is exactly what they informed
me over the phone when I called the RNS
for evaluation, and they informed me that
it's positioned in the brain, and depending
on the "settings" the batteries would have
to be replaced every 2-5 years, which
would mean brain surgery to replace the
batteries.


RNS INFO

Called the Responsive Neurostimulator System, or RNS, the device is nested in a cavity carved into the bone of the skull. According to its developer, Mountain View-based NeuroPace, battery-powered electrodes are placed in the parts of the brain that are damaged, and a computer chip within the RNS monitors the patient's brain waves. When it senses buildup of electrical energy preceding a seizure, it stimulates the affected area and disrupts the impending seizure pattern, the company says.

RNS RESEARCH INFO

The RNS system is a new way to try to control seizures. The RNS is an implantable device, manufactured by NeuroPace, Inc., which detects and responds to seizure activity. The RNS contains a small battery for power (changed every 3-5 years) and a microprocessor (computer chip) that detects and stores electrical activity from the brain. When the RNS detects a seizure, it responds by delivering electrical stimulation through the lead(s) (electrodes) to a small part of the brain to try to stop seizures.

[Bernard]

lol @ Birdbomb's post. It's true to an extent. Most venture capital is spent on big pharma looking for a return on investment. There are some studies being done on diets, neurofeedback and other alternatives, but most of the funding for these studies appears to come from non-profit groups (CURE, FACES, etc.) dedicated to finding cures.

[POSITIVEPERSON]

After my expereince with felbetol expirment I perfer the alternative ways !!!!!!!!

It was no fun being guniea pig!!!!!!!!! And the thought of them slicing my head open every 2 yrs. WOW that is pushing the envelope.

They really don't care about our quality of life .

There's pre op -post op and healing and to have to go thru that every 2 yrs is alot !!!!

DIet and homeopathy is much more kinder and gentler to us!!!!!!

There's quality of life with diet and homeopathy!!!!!!

RIVA

[hamatreya]

Thanks for the update Bernard. But to answer your question, yes the battery is placed inside the chip in the brain. That's why I'm not so enthusiastic about getting the Neuro Pace because they'll have to slice my head open every 2 years.

I came across this website and forum board largely by accident, but as a patient in the RNS investigational trial, I have to correct some erroneous information being dicussed.

The battery is located in the stimulator, which is implanted on the surface of the skull, NOT the brain. The only contact between the RNS and the brain comes from the electrodes which deliver stimulation.

While it is true the battery life is proving to be shorter than initally expected, the procedure for replacing it is not neurosurgery. A small incision is made in the scalp, the skin pulled back and the RNS exposed on the skull, the battery is snapped out and a new one placed in.

The procedure never involves removing any of the skull to expose the surace of the brain. Even changing lead points to the electrodes can be done without exposing the surface of the brain.

The description of being "sliced open" is correct to the extent that a slice is made in your scalp, then quickly closed after the battery change. The skull and brain are left alone during the battery repalcement.

The only neurosurgery involved is in the initial implant surgery, and if you have had a craniotomy before, as many RNS patients have, no new holes are drilled in the bone. Particularly compared to having a third of your skull removed for ten days during grid placement surgery, the implant surgery is a breeze. My first question in recovery was why didn't my head hurt.

It is also possible with advances in neuroimaging technology, particularly MRIs, (5t or more), that the epilepsy center you are working with will never have to place intracranial strips or grids.

And consider this- the more battery power you are using, the more stimulation the seizure focus is receiving, at least in theory leading to greater seizure control.

If you had the RNS implanted and received no stimulation, it would be pointless. If the battery wasn't running down, the device wouldn't help. Also, to get really into the weeds of it, solid state batteries which are MRI compatible are being developed specifically for neurostimulation which should dramtically increase battery life.

Any person signing up for a clinical trial of an investigatonal medical device which has not yet recieved final FDA approval is, to a certain extent, a guinea pig. The same would be true if you agreed to try a new anti-epileptic drug.

Patients in the study are asked not to discuss the post open-label (five months after implant surgery and beyond) results precisely because this is a clinical trial, and individual definitions of success can vary dramatically.

A good place to start for information is to ask a neurologist or clinical study coordinator for a copy of the consent form, which is both long and imposing. But it also explains, in minute detail, what will be expected of you as a participant in the study. Anecdotal accounts in the media are far less helpfull.

The neuropschyc team we work with calls the Neuropace quality of life questionnaires the "don't worry, be happy" surveys. Don't assume receiving neurostimulation will have a dramtic impact on your life.

And there can be daily frustration with the RNS. Being a RNS patient requires an enormous time commitment for the forseeable future . You will be tethered to the study center where the impalnt surgery took place, and improvement may seem to happen at a glacial place.

True. there is the potential for infection when a cut is made in the hair and skin, but the idea of a battery replacement procedure being the only reason for not pursuing the potential value of responsive neurstimulation is unfortunate.

It is also unfortunate that a clinical trial coordinator would suggest a percentage of success for the RNS. They are not told which patient initially has the device delivering stimulation or not, end even the treating neurologist doesn't have this information. To try and quantify success at this stage is irresponsible.

[Bernard]

Hi hamatreya, welcome to the forum.

The battery is located in the stimulator, which is implanted on the surface of the skull, NOT the brain. ... the procedure for replacing it is not neurosurgery. A small incision is made in the scalp, the skin pulled back and the RNS exposed on the skull, the battery is snapped out and a new one placed in.

That makes a lot more sense than what was described above. Thanks for clarifying!

It is also unfortunate that a clinical trial coordinator would suggest a percentage of success for the RNS. They are not told which patient initially has the device delivering stimulation or not, end even the treating neurologist doesn't have this information. To try and quantify success at this stage is irresponsible.

That's what I was thinking. The results have not been released yet, so how could anyone claim x% responded in any way?

[POSITIVEPERSON]

Welcome to the board Hamatreya!!!!!! Nice meeting you !!!!!!!!!!!

Thank you for correcting the misunderstanding!!!!!!!!!!!!!!!

Gives us one more option!!!!!!!!! OPtions are important!!!!!!

thanks again

nice meeting you
Riva

[brain]

Bernard:

Then this leaves the question of the
phone call when I consulted with the
evaluation with the ARNP of the RNS
to see if I qualified and when they
obtained information - she then informed
me how it all worked and proceeded how
the process worked. The main reason
why I backed off was the fact of the
thought of having brain surgery to have
the batteries replaced when needed
was too much to comprehend, and to
the fact, there was no ability to turn the
unit ON/OFF (as I've heard stories of the
VNS that had went haywire and no way
of turning the unit off).

They hung up on me - and I never spoke
with them again. I was a candidate for
VNS but the stories and research of it
(FDA) was what caused me to back off.

The number I called was:
1-866-903-3678

My concern here is:

EXACTLY WHERE ARE THE BATTERIES
POSITIONED?

WHERE IS THE ABILITY TO TURN THE UNIT
OFF IMMEDIATELY / TO DISABLE IT IF
IN THE EVENT OF EMERGENCY?

[brain]

Hamatreya

Glad you stopped by and made your posting!
Quite a contrast from what they (RNS) had
been informing me via the phone. I'm glad it
all went well with you and it's been working
for you!

[vtsammy]

Hello Hamatraya. Welcome to the forum. I know you are not allowed to discuss results w/ us. But can you discuss with us what you've been going through? How long have you had treatment for? Where are you having your treatment? I am at a hospital in Washington DC. I am going to meet w/ the Neurosurgeon tomorrow to ask questions. But thanks for the info Hamatraya.

Sam

[Bernard]

brain, the batteries are located in the generator (just like with the VNS). The generator is located between the skull and scalp (unlike the VNS).

hamatreya, does the RNS have a magnet system like the VNS where patients can turn it off manually?

It sounds to me like NeuroPace may not be communicating very effectively on the issue of the battery replacement. I'll forward that along to one of my contacts.

[Birdbomb]

This is exciting! I love reading any new info on this!

Thank you hamatreya for your very knowlegable input.

[brain]

I'm still interested in the RNS to
see if I still qualify ... if I can ever
get through them! Sometimes I
just wished that car accident didn't
make me deaf overnight!